Sudeep Pharma Receives Gujarat FDA Approval for New Nandesari Manufacturing Facility

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Sudeep Pharma Limited (NSE: SUDEEPPHRM; BSE: 544619) has received approval from the Gujarat Food and Drug Control Administration to commence manufacturing operations at its new pharmaceutical greenfield facility at 179 Nandesari, Gujarat. The approval confirms that the facility’s manufacturing systems, quality controls and compliance framework meet the requirements for starting operations. The new plant has an installed annual capacity of 51,200 metric tonnes and will expand the company’s manufacturing infrastructure for pharmaceutical excipients, food and nutrition ingredients, and specialty mineral-based products.

Commercial supplies from the facility are expected to begin in the second half of FY2027, following the completion of customer qualification processes. The company will now advance customer onboarding and audits at the site. Approximately 60% of the plant’s capacity has been allocated to Sudeep Pharma’s existing pharmaceutical, food and nutrition portfolio. The remaining capacity will support newer product categories, including phosphates, glycinates, gluconates and citrates.

The facility will also provide additional capacity for specialised, higher-value ingredients. This includes bisglycinates, for which production capacity at the company’s existing mother plant was constrained. The new infrastructure is expected to help Sudeep Pharma increase output, meet customer requirements and expand its presence in specialised ingredients.

Commenting on the approval, Sujit Bhayani, Managing Director of Sudeep Pharma Limited, said the facility would add manufacturing capacity and strengthen the company’s ability to serve customers in India and international markets. He said the approval would allow the company to accelerate customer qualification and audit processes, supporting the onboarding of both existing and new customers. The plant would also provide greater flexibility to expand across established product lines and newer categories, including specialised ingredients such as bisglycinates.

The additional capacity is intended to support portfolio diversification and help the company address demand for value-added ingredients across pharmaceutical, food and nutrition applications. Sudeep Pharma also expects the facility to create opportunities in regulated markets and support its expansion into international markets.

Sudeep Pharma Limited manufactures pharmaceutical excipients, food and nutrition ingredients, and specialty mineral-based solutions for customers in India and overseas. Its product portfolio serves pharmaceutical, food, nutrition and other specialised applications.

The company’s operations are built around mineral chemistry, manufacturing capabilities and quality control. It continues to expand its production infrastructure, develop higher-value products and pursue new business opportunities, including battery materials through its subsidiary. The Nandesari facility forms part of Sudeep Pharma’s efforts to increase capacity and broaden its product offering as customer requirements evolve across its existing and newer markets.